CLASS II Device recall · Reported 13 Nov 2019 · FDA Enforcement Report

SCFE (slipped capital femoral epiphysis) Knobs recalled by Pega Medical

Pega Medical is recalling SCFE (slipped capital femoral epiphysis) Knobs for Driver and Orthopedic surgical, distributed nationwide in the US. The recall was initiated on 2 Oct 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalogue Numbers: SCF-KNB265, SCF-KNB273, SCF-KNB365, SCF-KNB373; Lot Numbers: 160428-03, 160428-04, A182-05, A182-15, 160603-05, 160603-06, A183-06

Quantity recalled31 devices

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-0270-2020
FDA event ID: 84017
Recalling firm: Pega Medical, Laval, N/A
Classification: Class II
Status: Terminated
Recall initiated: 2 Oct 2019
FDA classified: 1 Nov 2019
Reported: 13 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

2 Oct 2019	Recall initiated by company
1 Nov 2019	Classified by FDA	+30 days
13 Nov 2019	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

There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.

Product as listed by the FDA

SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery

Where it was distributed

Nationwide distribution to CA, FL, GA, HI, LA, MA, MO, NC, NY, OK. International distribution to AUSTRALIA, CANADA, DENMARK, GERMANY, ISRAEL, MEXICO, ROMANIA, RUSSIA, UNITED ARAB EMIRATES, UNITED KINGDOM

Nationwide California Florida Georgia Hawaii Louisiana Massachusetts Missouri North Carolina New York Oklahoma

Questions about this recall

Why was it recalled?

There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.

Which lots are affected?

Catalogue Numbers: SCF-KNB265, SCF-KNB273, SCF-KNB365, SCF-KNB373; Lot Numbers: 160428-03, 160428-04, A182-05, A182-15, 160603-05, 160603-06, A183-06

Where was it sold?

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 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 Pega Medical

All 9

Reported	Class	Recall	Company	Reason	Where
27 May 2020Device	CLASS III	Orthopedic manual Surgical Instrument handle recalled by Pega Medical	Pega Medical	Device Malfunction	Nationwide
21 Aug 2019Device	CLASS II	SLIM Handle recalled by Pega Medical	Pega Medical	Other	8 states
2 Dec 2015Device	CLASS II	Scfe Driver (Scf-MLD273 & Scf-MLD265) instrument used recalled	Pega Medical	Other	FL, TN
8 Jul 2015Device	CLASS II	Slipped Capital Femoral Epiphysis recalled by Pega Medical	Pega Medical	Other	FL, TN
6 May 2015Device	CLASS II	Female Driver recalled by Pega Medical	Pega Medical	Device Malfunction	4 states

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide