Peritrochanteric Nail System 29202

• FDA 510(k) K050118 decided 16 Feb 2005 Active· +1 more in the status table
• FDA GUDID UDI-DI 00888480262602 listed 24 Oct 2015 Listed

• 13 recalls, same reason

  • Terminated Z-2235-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2231-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2240-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2242-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2241-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2234-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2233-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2236-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2239-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2237-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2238-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2230-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2232-2018 FDA Class II ·initiated 16 May 2018

  The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.

• • Terminated Z-0087-2017 FDA Class II ·initiated 2 Aug 2016

  The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and one (1) 467255-02 Plain Tip Guide Pin. The G-PIN 2.8BL 3.2PL 60 CM 2PK may have been packaged incorrectly either with two (2) 467265-01 Ball Tip Guide Pins and zero (0) 467255-02 Plain Tip Guide Pins or with zero (0) 467265-01 Ball Tip Guide Pins and two (2) 467255-02 Plain Tip Guide Pins. If the G-PIN 2.8BL 3.2PL 60 CM 2PK contains the incorrect combination of Plain Tip Guide Pins and Ball Tip Guide Pins, the surgeon would either have to implant the nail without the Plain Tip Guide Pin as a guide, ream with a Plain Tip Guide Pin, or choose to not ream the humeral canal. The risk associated with not having the correct combination can include a delay in surgery of less than 30 minutes, the reamer tip remaining in the distal humeral canal, or an iatrogenic fracture.

• 2 recalls, same reason

  • Terminated Z-1822-2016 FDA Class II ·initiated 1 Apr 2016
  • Terminated Z-1819-2016 FDA Class II ·initiated 1 Apr 2016

  Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

• • Terminated Z-1478-2012 FDA Not yet classified ·initiated 30 Mar 2012

  The Trochanteric Nail, lot 486130, was mislabeled as a right nail orientation but the contents are actually a left nail orientation

• • Terminated Z-0012-06 FDA Unclassified (pre-2012) ·initiated 24 Jun 2005 ·on shared 510(k) K050118

  Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 16 May 2018 Recall initiated FDA recalls Z-2242-2018
2. 16 May 2018 Recall initiated FDA recalls Z-2241-2018
3. 16 May 2018 Recall initiated FDA recalls Z-2234-2018
4. 16 May 2018 Recall initiated FDA recalls Z-2233-2018
5. 16 May 2018 Recall initiated FDA recalls Z-2236-2018
6. 16 May 2018 Recall initiated FDA recalls Z-2239-2018
7. 16 May 2018 Recall initiated FDA recalls Z-2237-2018
8. 16 May 2018 Recall initiated FDA recalls Z-2238-2018
9. 16 May 2018 Recall initiated FDA recalls Z-2230-2018
10. 16 May 2018 Recall initiated FDA recalls Z-2232-2018

11 earlier events are in the sections above.

Trade name

Peritrochanteric Nail System

Generic name

Bone nail implantable cap

Model / Ref / Catalog

29202

Primary DI / UDI-DI

00888480262602

510(k) Number

K050118 ↗

K831005 ↗

FDA product code

HSB, HTY

GMDN term

Bone nail implantable cap

Device class

Class II

Regulation number

888.3020, 888.3040

GUDID distribution status

In Commercial Distribution

Category: Bone nail end-cap

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