CLASS I Device recall · Reported 10 Sep 2014 · FDA Enforcement Report
Hip Orthopedia Pack - Blade Surgical #15 Stainles /steel recalled
Customed is recalling Hip Orthopedia Pack - Blade Surgical #15 Stainles /steel Gown XL Sms Impervious, distributed nationwide in the US. The recall was initiated on 20 May 2014 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2415-2014
- FDA event ID
- 68536
- Recalling firm
- Customed, Fajardo, PR
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 20 May 2014
- FDA classified
- 29 Aug 2014
- Reported
- 10 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 20 May 2014 | Recall initiated by company | |
| 29 Aug 2014 | Classified by FDA | +101 days |
| 10 Sep 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL (1) GOWN XL SMS IMPERVIOUS REINFORCED MMI Ill LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WIT APE LIF (4) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) DRAPE SHEET 41" X 58" SMS LIF (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (10) GAUZE 4" X 4" 4PLY (2) UTILITY BOWL 16oz LIF (1) CAUTERY TIP POLISHER LIF (1) SUTURE BAG FLORAL (1) BLADE SURGICAL#10 STAILESS STEEL (1) SURGICAL DURAPREP SOLUTION 26m! LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (10)GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGE PRE WASH 18" X 18" XRD LIF (1) CAUTERY PENCIL ROCKER SWITCH LIF (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) DRAPE INCISE ANTIMICROBIAL 23" X 33" (2) SHEET DRAPE 70" X 100" LIF (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS LIF (1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Where it was distributed
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
Questions about this recall
Is Hip Orthopedia Pack - Blade Surgical #15 Stainles /steel Gown XL Sms Impervious recalled?
Yes. Customed recalled Hip Orthopedia Pack - Blade Surgical #15 Stainles /steel Gown XL Sms Impervious on 20 May 2014. The recall is Class I and its status is Terminated. Recall number Z-2415-2014.
Why was it recalled?
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Which lots are affected?
Product code 900-1835, 3 lots: 113109763 131210771 140412619
Where was it sold?
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Customed
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|---|---|---|---|---|---|
| Device | CLASS II | Catalog Number: 900277 Suction Catheter Tray 14FR With Sodium recalled | Customed | Sterility | PR |
| Device | CLASS II | Catalog Number: 9002940 Obstetrical Surgical Pack Used by medical recalled | Customed | Sterility | PR |
| Device | CLASS II | Catalog Number: 900010 Suture Removal KIT Used by medical staff to recalled | Customed | Sterility | PR |
| Device | CLASS II | Catalog Number: 9001933 Ophtalmic Surgical Pack Used recalled | Customed | Sterility | PR |
| Device | CLASS II | Catalog Number: 900169 Universal Surgical Pack Used by medical staff recalled | Customed | Sterility | PR |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |